Good Automated Manufacturing Practice, GAMP, is something that we at Plantvision Compliance really have experience and knowledge in. As experts in computerized systems, we belong to the absolute top layer, both in Sweden and in Europe. We know, quite simply, how to apply GAMP 5 in the best possible way. Maybe you need a GAP analysis of one or more systems to see how you relate to the new GAMP 5 Second edition? Or a training course to stay ahead of the game? Thanks to our expertise, we can help you and your company with training tailored to your needs - or we can act as a knowledge partner. Or both.
In July 2022, the industry association ISPE released a new edition of Good Automated Manufacturing Practice (GAMP), the global guideline for validation and quality assurance of quality-critical computerized systems in Life Science. GAMP 5, Second Edition, is largely based on the same overall principles for GxP computerized systems as described in the previous GAMP 5 edition published in 2008.
What is the difference between first and second edition?
One reason why the GAMP guidelines have been so successful globally and have become a kind of industry standard for both life science companies and life science suppliers is that they have continuously reflected existing technology developments. Innovation and technological advances in recent years have led to the need to review and update the guideline.
Some of the changes made in GAMP 5 Second Edition include support for agile and iterative approaches and now both linear and iterative approaches are described for several types of processes. The new edition also addresses and encourages the increased use of system and software tools instead of traditional paper-based documentation for information, requirements, specifications, testing and traceability, etc.
The Second Edition of GAMP 5 continues to describe risk-based thinking at all stages of a system's life cycle, as part of aligning the activities that need to be performed to ensure that a quality-critical system is Compliant. A further update is that it includes clarification that an initial risk assessment should be carried out before the project phase and that risk assessment should then be carried out continuously during the project and throughout the system's continued life cycle. The new edition also includes guidance on the application of artificial intelligence (AI), machine learning, blockchain and cloud solutions, which is a good complement to the previous edition.
2 quick questions for one of our wizards
We had the opportunity to talk a bit with Lina Stange, Senior Expert Consultant at Plantvision and one of our wizards on GAMP 5 and all that it entails.
What do we need to do differently now that the new edition has arrived?
- The new edition offers more opportunities, but also places higher demands on risk assessment and critical thinking. For example, we can help the customer to do a GAP analysis against GAMP 5 2nd edition.
Do authorities require us to adapt our ways of working to GAMP 5 2nd edition?
- GAMP5 is not a regulation, but several regulatory authorities, including the FDA, have "recognized" GAMP 5 and some adaptations will be needed.
Do you want to know more about the GAMP 5 guidelines, what the new version might mean for you, or do you need support, training or analysis of the system? Do not hesitate to contact one of our experts!
NEW!
GAMP 5 Second Edition as interactive E-learning
We have now released a unique and groundbreaking GAMP 5 Second Edition training course! A three-hour interactive training that will teach you everything you need to know about the new edition. Smart and smooth, right?
